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Huadong Medicine’s subsidiary’s Caspofungin Acetate for Injection approved by the U.S. FDA

On July 23, Huadong MedicineThe company issued an announcement stating that its wholly-owned subsidiary Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Sino-US Huadong”) received a notice from the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) that the Abbreviated New Drug Application (ANDA) for caspofungin acetate injection submitted by Sino-US Huadong to the FDA has been approved. Caspofungin is an echinocandin that is active against the active cell growth sites of Candida and Aspergillus hyphae. It is currently clinically approved for the treatment of specific fungal infections such as Candida infections and invasive aspergillosis in adult patients and pediatric patients (3 months and older). https://finance.eastmoney.com/a/202507233465347927.html
- Source: drugdu
- 217
- July 25, 2025
Good news from AstraZeneca

Today (July 24), AstraZeneca announced that its Gefurulimab achieved significant efficacy in the Phase III PREVAIL clinical trial for adult patients with generalized myasthenia gravis (gMG). Generalized myasthenia gravis (gMG) is a rare, debilitating, chronic autoimmune neuromuscular disease characterized by loss of muscle function and severe weakness. Gefurulimab is a mini bispecific antibody (25kD) that contains an antibody heavy chain variable region targeting C5 and an antibody fragment that specifically binds to albumin. Its smaller molecular weight gives it better tissue penetration, and binding to albumin can prolong its half-life, making it a once-weekly subcutaneous injection therapy. In the Phase III PREVAIL clinical trial, Gefurulimab showed significant efficacy in adult patients with gMG who were positive for anti-acetylcholine receptor (AChR) antibodies. Compared with placebo, Gefurulimab showed statistically significant and clinically meaningful improvements in the total score of the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at week 26. In ...
- Source: drugdu
- 146
- July 25, 2025
A breakthrough in the cure of hepatitis B is in sight, and the share prices of leading pharmaceutical companies have doubled

Once upon a time, “hepatitis B is incurable” was a heavy burden on countless patients. But more and more innovative therapies indicate that the era of clinical cure for hepatitis B is about to begin. Recently, Cosun’s innovative hepatitis B drug projects have achieved key breakthroughs one after another: GST-HG141 (nericovir) started Phase III clinical trials, marking a key step towards the drug’s market launch and is expected to become a new milestone drug for hepatitis B worldwide; GST-HG131 was included in the list of breakthrough therapy products, becoming Cosun’s second innovative drug in the field of hepatitis B treatment to be recognized as a breakthrough therapy. As a result, Guangshengtang’s stock closing price increased by more than 100% for 10 consecutive trading days from July 3 to July 16. Aiming to cure hepatitis B, Guangshengtang starts a comeback Guangshengtang once dominated the Chinese liver disease market with its three ...
- Source: drugdu
- 598
- July 25, 2025
A new hotspot in the innovative drug market

After a long period of financial difficulties, French biotech company Abivax announced positive top-line results from two Phase III studies (ABTECT-1 and ABTECT-2) of its microRNA (miRNA) drug Obefazimod (ABX464) for the treatment of ulcerative colitis (UC). Obefazimod is an oral, first-in-class enhancer of miR-124 (an anti-inflammatory miRNA) developed by Abivax. ABTECT-1 (Study 105) and ABTECT-2 (Study 106) included a total of 1,275 patients worldwide. The enrollment population was balanced, and 47.3% of the subjects had insufficient responses to previous advanced therapies (biological agents/JAK inhibitors, etc.), including the largest JAK inhibitor failure population in Phase III UC trials to date. The primary endpoint was the clinical remission rate based on the modified Mayo score after 8 weeks of treatment. The results showed that in the pooled analysis of the two trials, the placebo-corrected clinical remission rate of 50 mg of obefazimod once daily reached 16.4% (p<0.0001). At the same time, ...
- Source: drugdu
- 185
- July 25, 2025
More than 3,000 cases confirmed! No specific medicine! Are we ready for Chikungunya virus?

Recently, Diana Alvarez, head of the WHO’s arbovirus team, said that the transmission of Chikungunya virus has been found in 119 countries and regions, about 5.5 million people are at risk of this mosquito-borne virus, and a large-scale epidemic may occur. Confirmed cases have appeared in China. Since July, Guangdong has reported cases of Chikungunya virus infection. As of July 22, the number of infected cases has exceeded 3,000, and this number is still rising. Chikungunya virus, a once ignored “hidden threat”, is now spreading at an alarming rate in some parts of China, posing a challenge to public health security. Faced with this sudden outbreak, people can’t help but feel anxious and uneasy: What exactly is the Chikungunya virus? What is the progress of vaccines and special medicines? What is Chikungunya virus? The name of Chikungunya virus (CHIKV) comes from the Makonde language in Tanzania, Africa, which means “bent ...
- Source: drugdu
- 172
- July 25, 2025
Sanofi Acquires Vicebio for $1.15 Billion, Enhancing Respiratory Vaccine Pipeline

Sanofi announced an agreement to acquire biotech company Vicebio Ltd for $1.15 billion, expanding its respiratory vaccine pipeline and future capabilities in vaccine design and development with Vicebio’s ‘Molecular Clamp’ technology. According to the terms of the agreement, Sanofi will acquire London-based Vicebio’s entire share capital for an upfront payment of $1.15 billion with milestone payments upwards of $450 million based on development and regulatory checkpoints. The deal is set to close in Q4 of 2025 and won’t drastically affect Sanofi’s Diving deeper Vicebio’s Molecular Clamp technology is one of the driving forces in the deal, as the technology enables researchers to stabilize naturally shaped viral proteins, enabling the immune system to recognize and react at an improved rate. This allows for accelerated development of liquid combination vaccines, which allows them to be stored in refrigerators. This eliminates the need for freezing and freeze-drying vaccines, making the production and distribution ...
- Source: drugdu
- 156
- July 25, 2025
COVID Boosters Protect People With Cancer

By Dennis Thompson HealthDay ReporterWEDNESDAY, July 23, 2025 (HealthDay News) — Cancer patients can be very vulnerable to a severe COVID infection, but COVID-19 vaccine boosters can be lifesavers for them, a new study says. COVID boosters reduced cancer patients’ hospitalizations and ICU stays by 29%, researchers report in JAMA Oncology. Overall, the vaccine boosters prevented one hospitalization or ICU admission for every 150 to 166 boosted patients, researchers found. “The reduction in hospitalizations was significant, and the number of patients we needed to treat to see a benefit to the boosters is quite low,” said senior researcher Jan Figueiredo, director of community health and population research at Cedars-Sinai Medical Center in Los Angeles. “This shows a great benefit to our cancer patients and should encourage patients to discuss vaccination with their healthcare providers,” she said in a news release. “Their immune systems can be weakened by their disease and ...
- Source: drugdu
- 154
- July 25, 2025
China’s innovative drug pipeline accounts for about 1/4 of the world’s total; Guangji Pharmaceutical fined 1.5 million yuan

National Medical Products Administration: Currently, China’s R&D pipeline for innovative drugs accounts for about 1/4 of the global total On July 23rd, according to statistics from the National Medical Products Administration, China approved 43 innovative drugs in the first half of the year, a year-on-year increase of 59%, approaching the annual number of approved innovative drugs of 48 in 2024. Yang Ting, Director of the Drug Registration Management Department of the National Medical Products Administration, stated that in terms of research and development pipelines, China currently accounts for about 1/4 of the world’s innovative drug research and development pipelines. In terms of clinical trials, we have about 3000 projects undergoing clinical trials every year, which ranks among the top in the world. It is reported that the National Medical Products Administration will focus on increasing policy supply, guiding and encouraging enterprises to carry out innovative drug research and development guided ...
- Source: drugdu
- 149
- July 25, 2025
【EXPERT Q&A】What contents need to be submitted for the registration application of domestic Class II medical devices?

Drugdu.com expert’s response: The registration of Class II medical devices in China requires submission of key documents covering risk analysis, technical specifications, testing reports, clinical evaluation, labeling, quality management systems, and authenticity declarations. Detailed requirements are outlined below: I. Foundational Qualification Documents Medical Device Registration Application Form: Must include core details such as product name, model/specification, structural composition, and intended use, signed and stamped by the legal representative or responsible person. Enterprise Qualification Proof: Copy of the business license (valid within its term). Medical Device Manufacturing License (if applicable; the registered product must fall within the approved scope). Personnel Qualification Proof: Identity, educational, or professional title certificates for the legal representative, enterprise leader, and quality manager (the latter must have a medical device-related background). II. Product Technical Documentation Product Technical Report: Covers design principles, structural composition, manufacturing materials, performance indicators, and production processes. Must provide the product technical requirement number and explain the basis for key ...
- Source: drugdu
- 126
- July 25, 2025
Targeting tumor cell stemness may hold the key to treating colon cancer more effectively

Colon cancer remains a major global health concern, ranking third among the most diagnosed cancers and leading causes of cancer-related death worldwide. One critical factor that makes treating colon cancer challenging is the presence of cancer stem cells. Though typically present in small populations, these powerful cells drive tumor growth, resist standard treatments, and often contribute to relapse. They achieve this through their “stemness,” a set of properties that enable these cells to self-renew and differentiate into other cell types. Thus, understanding how stemness might be controlled at the molecular level is essential for developing effective therapies for colon cancer. Over the past two decades, researchers have identified several key molecules involved in both the development of the colon and the progression of colon cancer. Among them are CDX1 and CDX2, two homeobox transcription factors that help establish and maintain the identity of intestinal epithelial cells. Another example is ...
- Source: drugdu
- 225
- July 24, 2025

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